Ethical Checklists for Clinical Research Projects and laboratory medicine: two tools to evaluate compliance with bioethical principles in different settings

Author:

Verona Julián1ORCID,Yilmaz Gülsen23,Zaninotto Martina4,Munsaka Sody5,Serdarevic Nafija67,Datta Sudip K.8,Wiencek Joesph9,Fink Nilda10

Affiliation:

1. Hospital de Balcarce “Dr. Felipe A. Fossati” , Balcarce , Buenos Aires , Argentina

2. Department of Medical Biochemistry , Ankara Yildirim Beyazit University School of Medicine , Ankara , Türkiye

3. Medical Biochemistry Laboratory , Ankara Bilkent City Hospital , Ankara , Türkiye

4. Department of Laboratory Medicine , University Hospital , Padova , Italy

5. Department of Biomedical Sciences , School of Health Sciences, University of Zambia , Lusaka , Zambia

6. Institute for Biochemistry , University of Sarajevo Clinics Center , Sarajevo , Bosnia and Herzegovina

7. Faculty of Health Sciences , University of Sarajevo , Sarajevo , Bosnia and Herzegovina

8. Department of Laboratory Medicine , All India Institute of Medical Sciences , New Delhi , India

9. Department of Pathology, Microbiology and Immunology , Vanderbilt University School of Medicine , Nashville , TN , USA

10. Fundación Bioquímica Argentina, Programa PROES , Ciudad Autónoma de Buenos Aires , Argentina

Abstract

Abstract Objectives To develop two ethical checklists to evaluate (i) management of ethical concerns in research projects and (ii) awareness of ethical conduct of healthcare laboratory professionals. Methods Comprehensive discussion among the members of IFCC Task Force on Ethics based on pertinent literature. Results This Checklist for Clinical Research Projects should be useful to evaluate research proposals from an ethical perspective before submitting it to an IRB or its equivalent, thereby diminishing rejection rates and resulting in more time-effective projects. The checklist designed to evaluate the ethical conduct in laboratory medicine could be useful for self evaluation (internal audits) and for certification/accreditation processes performed by third parties. Conclusions These checklists are simple but powerful tools useful to guide professionals to adhere to ethical principles in their practice, especially in developing countries where accredited ethics committees may be difficult to find.

Publisher

Walter de Gruyter GmbH

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